LEX Diagnostics Seeks 510(k) Clearance and CLIA Waiver Status for its VELO system to Deliver Highly Sensitive PCR Results

Shots:The US FDA has received 510(k) clearance & CLIA waiver application of VELO system for highly sensitive PCR results for respiratory pathogensLEX Diagnostics has completed US trials of the VELO system & Influenza/COVID assay during the 2024/2025 season & expects 510(k) clearance by late 2025 or early 2026, pending FDA reviewVELO system…